FDA 510(k)
FDA class 1
Substantially Equivalent
🇺🇸 United States
REAGENT FOR COULTER COUNTER MODEL 5+11
K Number: K821683
·
Decision Jun 24, 1982
Classifications
1
FEI Numbers
54
Registration Numbers
54
Same Product Code
37
Applicant Total
89
Review Days
16
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Basic Information
- Device Name
- REAGENT FOR COULTER COUNTER MODEL 5+11
- K Number
- K821683
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 864.8200
- Medical Specialty
- Hematology
- Decision
- Substantially Equivalent
- Applicant
- Fisher Scientific Co., LLC
- Date Received
- June 8, 1982
- Decision Date
- June 24, 1982
- Product Code
- GIF
- Advisory Committee
- Hematology
- Review Advisory Committee
- HE
- Third Party
- N
Classifications
This FDA 510(k) entry is associated with 1 FDA classification via its product code.
| Product Code | Device Name | Device Class | Medical Specialty |
|---|---|---|---|
| GIF | Diluent, Blood Cell | FDA class 1 | Hematology |
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Other Clearances by Fisher Scientific Co., LLC
| K Number | Device Name | ||
|---|---|---|---|
| K930415 | MICROHEMATOCRIT ROTOR | Mar 23, 1993 | Substantially Equivalent |
| K915825 | MARATHON 6K GENERAL-PURPOSE CENTRIFUGE | Mar 11, 1992 | Substantially Equivalent |
| K915441 | MARATHON 13K/H MICROHEMATOCRIT CENTRIFUGE | Jan 8, 1992 | Substantially Equivalent |
| K890534 | MODIFIED URIQUAL(TM) URINALYSIS CONTROL LEVEL 1 | Mar 8, 1989 | Substantially Equivalent |
| K881275 | URIQUAL(TM) URINALYSIS CONTROLS (HUMAN) I & II | May 16, 1988 | Substantially Equivalent |
| K874054 | FISHER DIAGNOSTICS HEMATALL III LAS REAGENT | Oct 20, 1987 | Substantially Equivalent |
| K872916 | HISTOMATIC SLIDE STAINER, CODE-ON VERSION | Sep 14, 1987 | Substantially Equivalent |
| K871058 | SERACHEM LIQUID SPINAL FLUID CONTROL (HUMAN) | Apr 6, 1987 | Substantially Equivalent |
| K863224 | HEMATALL-C PLUS HEMATOLOGY CONTROLS | Oct 29, 1986 | Substantially Equivalent |
| K862318 | FISHER DIAGNOSTICS HEMATALL-C CALIBRATOR | Jul 10, 1986 | Substantially Equivalent |